The regulatory landscape is fast changing with the advent of modern technologies supporting companies in understanding disease patterns, addressing customer needs by bringing in customized therapies. The challenging landscape is largely a result of increase disease burden, new disease areas, ageing population and ever increasing R&D costs. In addition, business competition has forced bio pharmaceutical companies to expand their frontiers to attain global reach, launching their products in many regions and countries, and therefore exposed to myriad, and sometimes diverse, regulatory requirements and operating standards.
Regulatory Affairs play key role in all these areas. Though a matured discipline in the industry, majority of the daily questions Reg Affairs teams need answers are situation or context based. Reading several 100s of pages of new guidelines or regulations is not practical anymore because of time pressures and also stagnant RA budgets. They need answers that are customized to their situation on hand or relevant to their products and countries. From various Health authority sites, the can get lot of information which they need to synthesize and arrive at conclusions which again demands time.
Automation is a definite help to Regulatory Affairs. But they need “smart” automation and not routine task automation. Hence MakroCare developed platform utilizing Artificial Intelligence called as RegAI.
RegAI scans guidelines and regulation documents from different countries continuously and parses for key information based on the defined rules in the system spanning different areas like Commercial, Clinical, Manufacturing, Labeling, Promotion and other key areas. For each clientele based on their current products, the countries they are in and the life cycle they are going through are taken as preliminary hooks. RegAI engine runs daily and when any relevant matches happen; it alerts clients on what is the proposed change and how that will affect their so-and-so product in a certain country.
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